EXPERIMENTAL STUDIES ON THE TOLERABILITY OF PALE SULFONATED SHALE OILFOLLOWING LOCAL AND SYSTEMIC APPLICATION

Ichthyol(R), pale, a pale sulfonated shale oil, is used for the treatm ent of inflammatory skin diseases. The studies conducted were carried out to obtain information on the risk following dermal application of sulfonated shale oil, pale. Corresponding to the administration route planned for man the drug was applied by topical and systemic administr ation. Studies were conducted on the acute, subacute and chronic toxic ity, and the teratogenic, mutagenic and carcinogenic potential. Sulfon ated shale oil, pale was found to be very well tolerated whether admin istered for a short period or over a long time. There were no indicati ons for tetratogenic, mutagenic or carcinogenic effects. The therapeut ic range (ratio of the toxic dose in animals and the therapeutic human dose) for topical administration is > 30 depending on animal species, frequency of administration, dose-level employed and the toxicologica l question posed. The results of the toxicological studies coincide wi th the almost 70 years of experience that the drug is well-tolerated b y man.